The document is a joint letter from four major academic and research associations (Association of American Medical Colleges, Association of American Universities, Association of Public & Land-grant Universities, and Council on Governmental Relations) addressed to the National Institutes of Health regarding the recent expansion of the definition of "clinical trial" through newly published NIH case studies. The associations express significant concerns that this expanded interpretation blurs the boundary between fundamental/basic health-related research and clinical trials, thereby imposing inappropriate and potentially burdensome regulatory requirements—such as mandatory ClinicalTrials.gov registration, new training obligations, altered grant application processes, and additional administrative procedures—on studies not intended to alter health outcomes but rather to improve scientific understanding. They caution that the case study examples lack clarity and consistency, likely resulting in confusion and uneven application among researchers and institutions, which could hinder scientific progress, restrict access to funding, and misrepresent fundamental research activities to the public.
The letter urges the NIH to reconsider this broader application, emphasizing that the consequences of designating basic research as clinical trials are substantial and may place undue strain, particularly on institutions with limited resources. The associations support NIH’s goals of transparency and rigorous results reporting but argue that these aims can be achieved more effectively through alternative, less disruptive approaches that recognize the distinct nature of basic research. They provide selected examples in an appendix to illustrate cases where studies—designed to answer foundational scientific questions rather than to study interventions affecting health outcomes—should not be classified as clinical trials. The signatories reaffirm their willingness to collaborate with the NIH to craft solutions that both advance transparency and uphold the integrity and efficiency of biomedical research.
